MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA

Catalog Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

The sample and customer's calibration and qc results were requested but not provided.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

Event Description

The initial reporter received questionable elecsys total psa and elecsys free psa results for one patient sample with a cobas e 801 module serial number unknown.The free psa value was greater than the total psa value.The total psa result was 0.19 ng/ml.The free psa result was 0.25 ng/ml.The questionable results were reported outside of the laboratory.This medwatch is for free psa.Refer to the medwatch with patient identifier (b)(6) for the total psa assay.

• Brand Name: ELECSYS FREE PSA IMMUNOASSAY
• Type of Device: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13537388
• MDR Text Key: 292191898
• Report Number: 1823260-2022-00388
• Device Sequence Number: 1
• Product Code: MTG
• UDI-Device Identifier: 07613336154397
• UDI-Public: 07613336154397
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1